FDA.reportPublic FDA data

Atropine sulfate

Product NDC
42799-826
11-digit product format
427990826
Labeler code
42799
Product ID
42799-826_0e312e98-b1a3-4746-b074-b0cd28aba14e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atropine sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Edenbridge Pharmaceuticals LLC.
Application
ANDA219013
Marketing category
ANDA
Marketing start
2026-05-06
Substance
ATROPINE SULFATE
Active strength
10 mg/mL
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Atropine sulfate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATROPINE SULFATE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii03J5ZE7KA5
Rxcui1190655

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c78bd43-efb4-4aeb-b7d8-eff1532f7822Product name420250801
41231c1e-8789-4da7-ac52-77fa90a85bf5Product name220250304
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0Product name220250214
5f84b7a7-523a-f042-dffb-1dadcd9b2407Product name420240110
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95caProduct name120230719
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0Product name320230317
dfd25202-b8d2-4628-9213-f3e0f9eafce5Product name420210513
4199bf9b-4718-828a-6dd6-ac2fbbd61687Product name120140508
4edd8af5-cea7-ae42-8023-e91c5335db1dProduct name120140508
d3908afb-7784-440f-c406-88294732d36aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42799-826-01Atropine sulfate2 mL in 1 BOTTLESOLUTION/ DROPS22
42799-826-01Atropine sulfate1 in 1 CARTONSOLUTION/ DROPS12
42799-826-02Atropine sulfate5 mL in 1 BOTTLESOLUTION/ DROPS52
42799-826-02Atropine sulfate1 in 1 CARTONSOLUTION/ DROPS12
42799-826-03Atropine sulfate1 in 1 CARTONSOLUTION/ DROPS12
42799-826-03Atropine sulfate15 mL in 1 BOTTLESOLUTION/ DROPS152

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42799-826-01ML - Milliliter42799-8267df2afe9-e0e4-4bc2-9c6c-31347b6d6a1412026-05-22
42799-826-02ML - Milliliter42799-8269a595f8b-5658-44ac-b3d4-262e494a457012026-05-22
42799-826-03ML - Milliliter42799-8266c24b570-4f98-48cd-b5e7-ee47e39dfcac12026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190655atropine sulfate 1 % Ophthalmic SolutionPSNb39f5876-5d6f-4a8f-bd24-bd4be24ff5682
1190655atropine sulfate 10 MG/ML Ophthalmic SolutionSCDb39f5876-5d6f-4a8f-bd24-bd4be24ff5682
1190655atropine sulfate 1 % Ophthalmic SolutionSYb39f5876-5d6f-4a8f-bd24-bd4be24ff5682

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42799-826-01427990826011 BOTTLE in 1 CARTON (42799-826-01) / 2 mL in 1 BOTTLE1 bottle2026-05-06NoNoHistorical
42799-826-02427990826021 BOTTLE in 1 CARTON (42799-826-02) / 5 mL in 1 BOTTLE1 bottle2026-05-06NoNoHistorical
42799-826-03427990826031 BOTTLE in 1 CARTON (42799-826-03) / 15 mL in 1 BOTTLE1 bottle2026-05-06NoNoHistorical